New York Times Examines Recent Allegations That Eli Lilly Concealed Evidence Linking Prozac to Increased Suicidal Thoughts

The New York Times on Monday examined how the recent publication of an article in BMJ about Prozac, an antidepressant manufactured by Eli Lilly, could make the "staid, usually methodical world of medical journals ... suffer its own black eye" (Meier, New York Times, 1/17). BMJ on Jan. 1 published an article based on company documents that said Lilly has "long concealed evidence" Prozac can cause "violent and suicidal behavior." The documents, sent anonymously to BMJ, were part of a 1994 lawsuit against Lilly filed on behalf of victims of a gunman in Kentucky under treatment with Prozac who allegedly killed eight individuals and himself. The jury found in favor of Lilly, but the company later disclosed a previously reached settlement with the plaintiffs. According to BMJ, the documents, which were not presented during the trial, could indicate a link between Prozac and an increased risk for violence and suicidal thoughts. One of the documents found that 38% of patients who took Prozac in clinical trials reported "new activation" -- which includes symptoms of agitation and aggressiveness -- compared with 19% of those who took a placebo, BMJ reported. According to BMJ, the documents on Prozac, sold generically as fluoxetine, is dated Nov. 8, 1988, but was never submitted to the FDA reviewer responsible for approval of the medication. An FDA advisory committee in 1991 found "no credible evidence" of a link between Prozac and increased risk for suicide. On Jan. 5, Lilly officials said that the company shared the documents cited by BMJ with FDA regulators 10 years earlier and that the documents included "no new clinical or scientific information." Lilly also submitted 16 annotated pages to FDA to explain the documents that BMJ said the company had concealed. The annotations included a chronology of submissions and communications between Lilly and FDA officials (Kaiser Daily Health Policy Report, 1/13). In addition, Eli Lilly has spent $800,000 to publish full-page advertisements in national newspapers to dispute the article in BMJ.

'Inaccurate and Defamatory'?
The article in BMJ was "cited in hundreds of television and newspaper reports" within days of publication, the Times reports. According to the Times, "While Lilly has not taken legal action, its lawyers have notified the publication that the company considers the article to be 'inaccurate and defamatory,' asserting that the records were not missing and that all their relevant data had been previously submitted to FDA." Alan Brier, chief medical officer at Lilly, said, "You put something out on the newswire with the imprimatur of a medical journal and people think it is fact." BMJ representatives declined to respond to written questions, but journal spokesperson Emma Dickinson said in an e-mail that BMJ "takes this issue very seriously" and will address the concerns raised by Lilly after they are reviewed (New York Times, 1/17).